Biologics and Biosimilars Manufacturing Certificate(Pre-Master's) (RAQA)

Biologics and Biosimilars Manufacturing (Pre-Master's)

We offer two certificates in biologics and biosimilars. The Certificate in Biologics and Biosimilars: Manufacturing provides a broad overview of the technical aspects of biologics manufacturing.

If you seek a program with a greater emphasis on regulatory aspects related to biologics and biosimilars, review the brochure for the Certificate in Biologics and Biosimilars: Regulatory Aspects.

Ever since the first biopharmaceutical product (recombinant human insulin) was approved in 1982, products derived through biotechnology have provided medical advances that include cell and gene therapies, therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors.

Temple's Certificate in Biologics and Biosimilars Manufacturing focuses on CMC aspects in the development and manufacture of these products, preparing students for positions in the biopharmaceutical industry and sharpening the skills and knowledge of those already working in this field.

This five-course certificate enables students to become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements. Technologies and unique considerations associated with the manufacture of biopharmaceutical products are discussed.

Students must complete four required courses:

  • Biotechnology: Bioprocess Basics (RAQA 5471)*
  • Biologics/Biosimilars: A Regulatory Overview (RAQA 5515*
  • Global CMCs – Biopharmaceuticals and Other Biologics (RAQA 5577)
  • Pharmaceutical Biotechnology (8005)

*Students with prior educational or biologics manufacturing experience may substitute a course from the electives below (with written permission from the RAQA Office).

One elective from:

  • Statistical Quality Control (RAQA 5451)
  • Validation of FUE (Facilities, Utilities, and Equipment (RAQA 5468)
  • Process Validation (RAQA 5474)
  • Advanced Good Manufacturing Practices – Defining “c” (RAQA 5479)
  • Production of Sterile Products (RAQA 5492)
  • Sterilization Processes (RAQA 5493)
  • Development of Sterile Products (RAQA 5501)
  • Microbiological Concepts in Pharmaceutical Manufacturing (RAQA 5512)
  • Cleaning Validation (RAQA 5516)
  • Vaccines: RA and QA Issues (RAQA 5572)
  • Statistical Design of Experiments (DOE) (RAQA 5627)
  • Process Monitoring (RAQA 5629)

Transfer credits are not accepted towards Temple’s certificate programs. 

Brochure - Biosimilar and Biologics Manufacturing Certificate

How to Receive the Certificate when you've completed the courses.

Submit the following items to the RAQA Office (hard copy only).

1. Application 

2. Photocopies of your undergraduate and graduate transcripts.

3. A transcript from Temple's Banner system of courses taken in the RAQA program.

4. Notice of Completion

All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.